Members of the Cancer Leadership
Council (CLC)—cancer patients, providers and researchers—write
to express support for the efforts of the Food and Drug Administration
(FDA) to safeguard the integrity of the agency’s advisory committee
deliberations and thus enhance public confidence in FDA drug review processes.
However, we are concerned that, in several respects, the Draft Guidance
goes too far by defining problematic financial interests on the part of
prospective advisory committee members in a manner that may deprive the
agency of vital scientific and medical expertise.

First, we question the propriety
of equating the financial interests of large non-profit entities like
academic medical centers or voluntary health organizations with those
of individuals who are employees or board members or otherwise affiliated
with such entities and who might be prospective advisory committee members.
Limits on participation should be based on the financial interests of
the individual, not on the quantum of funding to a non-profit institution
with which the individual is affiliated. Given the financial realities
of funding for clinical research, it is doubtful that many major academic
institutions would not be affected by the $50,000 limit, thus potentially
disqualifying all their physician researchers from participation as advisory
committee members. If this limit is not amended, there is a real risk
that the pool of qualified experts appropriate for advisory committee
service will be severely depleted.

Second, there is concern that
the Draft Guidance might be read to impute industry funds provided to
non-profit advocacy or educational organizations to individuals serving
as officers or board members of such organizations. For medical societies,
such an interpretation might mean that none of its leadership could serve
on advisory committees, which would unquestionably undermine the quality
of advisory committee review. For smaller non-profit patient advocate
organizations, it might deter engagement of highly qualified physician
researchers from involvement with our organizations, which would be a
crippling blow to efforts to attract top-quality leadership.

Neither of these problems is
insoluble. The focus simply needs to be shifted from the institution to
the individual. The quantum of funding to a large institution should have
no bearing on the qualification of individual employees or board members
unless a direct and personal impact on the individual can be identified.

We encourage FDA to revise
its Draft Guidance to address these concerns, alleviating burdens on advisory
committee participation by qualified individuals that lack direct and
substantial personal financial interest in the matters before FDA advisory
committees. It is important that the advisory committee process be free
of inappropriate financial influence, but perhaps equally important that
advisory committees have the benefit of guidance from highly qualified
physician researchers who can lead FDA to the best results for patients
dependent on the integrity of the agency’s review processes.